GENFIT Announces Active Participation in the 2nd Annual International NASH Day

A year ago, GENFIT gathered an international coalition to support The NASH Education Program and launch the 1st successful edition of International NASH Day

In 2019, GENFIT continues to support NASH awareness by participating in the 2nd International NASH Day on Wednesday, June 12th, hosted this year by the Global Liver Institute

Topics to include “NASH: the looming health crisis and methodologies for streamlining the diagnosis and management of high-risk NASH patients”

Lille (France), Cambridge (Massachusetts, United States), June 12, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that it will participate in the 2nd Annual International NASH Day, hosted by the Global Liver Institute, on June 12th, 2019, with the organization of conferences in Brussels, Belgium and New York City, U.S.A..

The second annual worldwide NASH awareness day

On June 12, 2018, the NASH Education Program held its inaugural session of the International NASH Day in more than 25 cities worldwide. As a resounding success, the Global Liver Institute, in conjunction with the American Liver Foundation, EASL International Liver Foundation, European Liver Patients’ Association, NASH Knowledge, Fatty liver Foundation and more, will host the 2nd Annual International NASH Day, dedicated to increasing awareness about NASH among the general public, targeted patients populations, the medical community, public health authorities, and the media.

NASH: The impeding global burden

On Wednesday, June 12, 2019, The NASH Education Program will host two conferences to take place in Brussels, Belgium and New York City, U.S.A in order to highlight the impeding burden of NASH on patients and healthcare systems worldwide. The sessions will delve into the initiatives and innovations currently in place and those in development to address the NASH health crisis.

Brussels, Belgium: 9:00AM-1:00PM CET, “NASH, a looming public health crisis: What are the challenges for health authorities and the medical community?”

New York City, U.S.A: 3:00PM-5:30PM EST, “NASH, a looming public health crisis: Identifying Challenges and Building a Common Vision for the Diagnosis and Management of High Risk Patients”

NASH currently affects 6-12% of US adults, and between 20% and 30% of the adult population with type 2 diabetes and obesity. Prevalence is expected to increase significantly in the coming years and have a dire socio-economic impact, with a predicted 63% increase in NASH prevalence by 2030. In the US, F3/F4 stages of NASH are expected to reach 8M cases, with an increase of 124% between 2015 and 2030[1]. Currently, the medical community faces great challenges in identifying and diagnosing high-risk NASH patients prior to progression to later stages of the disease, which include severe complications such as cardiovascular events, cirrhosis, and potentially liver failure or liver cancer. In light of this growing epidemic, there is an urgent need to develop cross-disciplinary approaches and efficient standard of care for the management of NASH patients.

Although NASH is extremely common, patients’ symptoms (fatigue, abdominal pain) are not NASH-specific. Therefore, diagnosis often occurs at later stages of the disease when the first symptoms of cirrhosis appear and liver injury is irreversible. Early identification and diagnosis in at-risk patients could play a key role in limiting disease progression. Today, liver biopsy remains the gold standard for diagnosis, however it is invasive and only performed by hepatologists, which greatly limit patients’ access to diagnosis. While other non-invasive tools are available, these tools lack the specificity required for accurate diagnosis. There is an urgent need for widely available, non-invasive methods to enable diagnosis by physicians beyond hepatologists to identify patients and ease their journey towards diagnosis.

“NASH” is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.

ABOUT THE NASH EDUCATION PROGRAM™

The NASH Education Program™, a GENFIT initiative, defines and drives initiatives in collaboration with an independent scientific committee composed of four international key opinion leaders in the hepatic and metabolic disease ecosystems in the U.S. and Europe. To learn more, visit www.the-nash-education-program.com.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery with a rich history and strong scientific heritage spanning almost two decades. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, the company is also developing a new, non-invasive and easy-to-access blood-based in vitro diagnostic test to identify patients with NASH who may be appropriate candidates for drug therapy. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 160 employees. GENFIT is a public company listed on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to Genfit. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2018 Registration Document filed with the AMF on February 27, 2019 under n° D.19-0078, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s final prospectus dated March 26, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

Important Information
The shares of Genfit have not been and are not being registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”) and neither Genfit, its shareholders or their affiliates intend to register its shares in the United States or to conduct a public offering of securities in the United States. Securities may not be offered or sold in the United States unless they are registered under the Securities Act, or exempt from registration.

Based on its historic and expected operations, composition of assets and market capitalization (which will fluctuate from time to time), Genfit does not expect that it will be a “passive foreign investment company” within the meaning of Section 1297 of the U.S. Internal Revenue Code of 1986, as amended, (a “PFIC”) for the current taxable year. However, the determination of whether Genfit is a PFIC is made annually, after the close of the relevant taxable year, and, therefore, it is possible that Genfit could be classified as a PFIC for the current taxable year or any future taxable year due to changes in the composition of its assets or income, as well as changes in its market capitalization.

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